Blood vessel sealing system

ABSTRACT

A method of and apparatus for sealing access openings into blood vessels using an expandable member in the blood vessel on a control member that extends out through the access opening and an applicator which inserts a preformed sealing material into the access opening over the control member to keep the control member and expandable member centered in the access opening and withdrawing the collapsed expandable member back through the sealing material after the access opening is sealed.

BACKGROUND OF THE INVENTION

This invention relates generally to the stopping of bleeding from bloodvessels through openings in the vessel wall and more particularlythrough surgically produced punctures for different medical procedures.

Certain medical procedures require the percutaneous puncturing of ablood vessel to gain access to the interior of the vascular system ofthe patient for the procedure to be conducted. Procedures that commonlyrequire such an percutaneous punctures are balloon angioplastyprocedures, arteriography, venography, angiography and other diagnosticprocedures that use blood vessel catheterization. Typically thepercutaneous opening or puncture is made into a relatively large bloodvessel such as a femoral artery. One of the difficulties in theseprocedures, however, is reclosure of the opening in the blood vesselwall after the procedure. In the past, manual pressure and/or mechanicalclamping pressure have been used to physically hold the opening closeduntil a blood clot formed with sufficient strength to keep the openingblocked until healing takes place. More recently, several techniqueshave been used to insert a collagen plug in the tissue access passage tothe blood vessel that promotes the formation of a coagulum at the vesselwall opening.

One such prior art technique simply inserts the collagen plug into theaccess passage in the tissue to the vessel wall puncture. The difficultywith this procedure is that there is no practical way to positivelylimit the protrusion of the collagen into the interior of the bloodvessel. This sometimes results in the collagen being inserted orsubsequently expanding through the blood vessel wall opening into thevessel lumen and causing a blood clot to form in the interior of theblood vessel. This is undesirable because the clot and/or the protrudingcollagen can dislodge and move along the blood vessel to cause anembolus. Also, the clot formed at the interior end of the puncture sitecan serve to undesirably restrict the blood flow past the site (i.e.thrombosis).

Another technique is to insert a sealing plug through the opening in theblood vessel wall with a first orientation and then turned to anorientation such that it will not pass back out through the opening. Thesealing plug is manipulated by a lanyard which extends back out throughthe tissue access passage exteriorly of the patient's body to bemanually held. The collagen plug is then passed down over the lanyardwhile the sealing plug is manually held in the blood vessel wallopening. Enough seepage of blood around the sealing plug is present toform the clot at the blood vessel wall opening. The sealing plug is leftin position in the blood vessel wall and is made out of a material whichis absorbable by the body over a several weeks or months period. Theproblem with this technique is that the sealing plug may break loosebefore it is absorbed by the body and cause a blockage of the blood flowthrough the blood vessel. The sealing plug may be a nidus for a bloodclot to form and subsequently dislodge resulting in embolization.Another potential problem in leaving a device inside the vessel wall isthat the device, like any foreign body, may erode the wall of the vesselor promote extensive intravascular scaring both of which potentiallywill disrupt vessel architecture.

SUMMARY OF THE INVENTION

These and other problems and disadvantages associated with the prior artare overcome by the invention disclosed herein by providing a techniquefor implanting a collagen plug in the tissue access passage to thepercutaneous puncture or opening in a blood vessel which insures thatthe end of the plug does not extrude through the blood vessel wallopening into the blood vessel lumen. A tamponading means located insidethe blood vessel lumen during installation of the collagen plug servesto positively prevent the collagen plug from being inadvertently pushedthrough the blood vessel wall opening as it is installed but which isremoved after installation of the collagen plug so that no protrusion orother dislodgable material is left in the interior of the blood vesselafter the procedure is completed. The tamponading means is selectivelyexpandable to an expanded size and shape such that it will not pass backout through the blood vessel wall opening and its position in the bloodvessel is controlled by a control member extending exteriorly of thepatient for easy manipulation. For removal, however, tamponading meansis selectively collapsible to a collapsed condition small enough to passback out through the installed collagen plug without interfering withthe coagulum forming capability of the collagen plug. The technique issimple to use and the location of the collagen plug is inherentlyaccurately positioned at the blood vessel wall opening independently ofvariances in the patient's skin and tissue thickness at the puncturesite and without premeasuring or adjustment of the applicator.

The method of the invention is directed to the sealing a percutaneouspuncture through a blood vessel wall comprising the steps of inserting acollapsed expandable tamponading member attached to a control memberinto the blood vessel lumen through the blood vessel wall puncture sothat the control member extends out of the patient through the accesspassage to the skin surface; expanding the tamponading member to a sizelarger than the blood vessel wall puncture; pulling the expandedtamponading member back against the blood vessel wall opening using thecontrol member to form a seal at the interior end of the blood vesselwall puncture; inserting a collagen plug into the access passage aroundthe control member while the seal is maintained at the blood vessel wallpuncture until the leading end of the collagen plug is located at theexterior end of the blood vessel wall puncture; then collapsing thetamponading member to the collapsed condition; and retracting thecollapsed tamponading member back through the collagen plug. Thecollagen plug has a preformed passage therethrough which slidablyreceives the control member to allow placement of the collagen plugalong the control member. The collagen serves to induce a coagulum thatseals the outside end of the puncture in the blood vessel wall. Afterthe collapsed tamponading member is pulled back through the collagenplug, the collagen plug self seals any opening through the plug left bythe passage of the expandable member. The collagen plug may be housed ina retractable barrel while the collagen plug is inserted into the accesspassage and the barrel then retracted from around the collagen plugwhile maintaining the collagen plug in a substantially fixed position inthe access passage. The barrel may be retracted fully or partially fromaround the collagen plug before the expanded tamponading member iscollapsed and withdrawn. The method may also include visually indicatingwhen the projecting end of the collagen plug is located at the exteriorend of the blood vessel puncture. The collagen plug may also be backedup while the collapsed tamponading member is withdrawn through the plugto insure that the plug remains in place. The collagen plug may also beurged slightly toward the blood vessel wall puncture to compensate forany loss in volume of the collagen plug as it turns into a gelatinousmass.

The apparatus of the invention comprises a temporary sealing arrangementincluding an elongate flexible control portion small enough to passthrough the blood vessel wall puncture with an expandable tamponadingportion on the projecting end of the control portion collapsible to acondition smaller than the blood vessel wall puncture and expandable toa condition larger than the blood vessel wall puncture so that it willnot easily pull back through the puncture. An applicator is provided toinstall the collagen plug in the access passage through the skin andtissue of the patient down to the exterior end of the blood vessel wall.The applicator cooperates with the control portion of the temporarysealing arrangement to fixedly locate the applicator with respect to theexterior end of the blood vessel wall and facilitate the positioning ofthe collagen plug with respect to the exterior end of the blood vesselwall puncture. The applicator includes a plug carrying assembly with aprescribed length used to insert the collagen plug. The control portionof the sealing arrangement includes indicia spaced a prescribed locatingdistance from that side of the expanded tamponading portion facing thepuncture to provide a visual indication that the leading end of thecollagen plug is located at the exterior end of the blood vessel wallpuncture. The plug carrying assembly has an installation barrel defininga plug carrying chamber therein adapted to receive the collagen plug forinstallation in the access passage and a retraction arrangement isprovided for selectively retracting the installation barrel from aroundthe collagen plug while maintaining the plug at a substantially fixedposition relative to the exterior end of the blood vessel wall puncture.The applicator may have a tightening mechanism for pulling the expandedtamponading portion of the temporary sealing arrangement tighter againstthe blood vessel wall puncture as the installation barrel is withdrawnfrom around the collagen plug. The applicator may also have an urgingmechanism for urging the exterior end of the collagen plug toward theblood vessel wall with a slight force just sufficient to offset volumeloss as the collagen plug softens to a gelatinous mass on contact withbody fluids. This is especially true while the collapsed tamponadingmember is being withdrawn. The expanded tamponading portion of thesealing arrangement may be an inflatable balloon with an inflation lumenthrough the control portion for use in selectively inflating the balloonto the expanded condition.

These and other features and advantages of the invention will becomemore clearly understood upon consideration of the following detaileddescription and accompanying drawings wherein like characters ofreference designate corresponding parts throughout the several views andin which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the invention;

FIG. 2 is an enlarged longitudinal cross-sectional view of theapplicator;

FIG. 3 is an enlarged longitudinal cross-sectional view of theexpandable tamponading member;

FIG. 4 is an enlarged longitudinal cross-sectional view of the couplingarrangement on the end of the control member;

FIGS. 5-9 illustrate one embodiment of the method of the invention;

FIG. 10 is an enlarged longitudinal cross-sectional view of anotherembodiment of the expandable tamponading member;

FIG. 11 is a perspective view of a second embodiment of the invention;

FIG. 12 is an enlarged transverse cross-sectional view taken along line12-12 in FIG. 11;

FIG. 13 is an enlarged transverse cross-sectional view taken along line13-13 in FIG. 11;

FIG. 14 is an enlarged transverse cross-sectional view taken along line14-14 in FIG. 11;

FIG. 15 is an enlarged perspective view of the collagen plug used inthat embodiment of the applicator seen in FIGS. 11-14;

FIG. 16 is a perspective view of a third embodiment of the invention;and,

FIG. 17 is a longitudinal cross-sectional view of the collagen plug ofthe third embodiment of the invention; and

FIG. 18 is a longitudinal cross-sectional view of another embodiment ofthe invention.

These figures and the following detailed description disclose specificembodiments of the invention, however, it is to be understood that theinventive concept is not limited thereto since it may be embodied inother forms.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

the blood vessel sealing system 10 is used to stop the bleeding from apercutaneous puncture BVP made in the wall BVW of a blood vessel BV asan incident to a medical procedure. Typically, the blood vessel BV usedis a femoral artery in the groin region with a relatively large vesselpassage or lumen BVL to facilitate locating the blood vessel and permitsa sufficiently large puncture to be made through the wall BVW thereof tocarry out the procedure. Medical procedures which are typicallyperformed through such an puncture are angioplasty and other procedureswhich pass a catheter or other type probe into and along the bloodvessel lumen BVL. When such a procedure is performed, an initialpercutaneous puncture with an appropriate needle is made from thepatient's skin through the tissue and the blood vessel wall into theblood vessel lumen and a guide wire installed. The needle is thenremoved leaving the guide wire in place and a tapered introducer guidesheath GS is installed over the guide wire to enlarge that portion ofthe puncture through the skin and tissue into an access passage AP whilethe blood vessel wall puncture BVP remains at about the originalpuncture size. The guide sheath GS serves to keep the passage open andprevent further damage to the tissue and skin around the passage. Theguide sheath GS is removed after the procedure is completed. This sheathGS assists in the installation of the sealing system 10 as will becomemore apparent.

Referring to FIG. 1, it will be seen that the sealing system 10embodying the invention includes generally a temporary sealing assembly11, a collagen plug 12 and an applicator 14. The sealing assembly 11 isinserted into the blood vessel lumen BVL through the introducer guidesheath GS and then the sheath removed leaving the sealing assembly inplace. The sealing assembly 11 serves to temporarily seal the interiorend of the puncture BVP in the blood vessel wall BVW while the collagenplug 12 is placed in the access passage AP to the exterior end of thepuncture BVP. After the collagen plug 12 is installed, the temporarysealing assembly 11 is removed through the collagen plug to insure thatnothing protrudes into the blood vessel lumen BVL to cause problemslater. The applicator 14 serves to install the collagen plug 12 in theaccess passage AP around the temporary sealing assembly 11 so thecollagen plug 12 can cause a coagulum to form at the exterior end of theblood vessel wall puncture BVP and stop the bleeding through thepuncture.

The sealing assembly 11 includes an elongate flexible control member 20on which is mounted an expandable tamponading member 21. The controlmember 20 is designed for the projecting end 22 thereof to pass throughthe guide sheath GS in the access passage AP and then through thepuncture BVP in the blood vessel wall BVW into the blood vessel lumenBVL while the opposite end 24 thereof remains exteriorly of the patient.The projecting end 22 extends through the tamponading member 21sufficiently for the control member 20 to still extend into the bloodvessel lumen BVL after the tamponading member is removed from thepatient so that the tamponading member 21 can be reinserted if necessaryin the event of a failure. The exterior end 24 of the member 20 isprovided with a coupling 25 for connection to an expanding mechanism 26for selectively expanding the tamponading member 21 from a collapsedcondition as seen by solid lines in FIG. 1 closely adhering to thecontrol member outside surface to an expanded condition as will becomemore apparent.

It will be appreciated that the tamponading member 21 may bemechanically, electrically, pneumatically or hydraulically expanded andcollapsed without departing from the scope of the invention. Theparticular expanded exterior configuration of the tamponading member 21can be selected depending on the particular circumstances of use. Theconfiguration may be elongated in one direction and/or may have aflattened side facing the blood vessel wall puncture BVP after thetamponading member 21 is located in the blood vessel lumen BVL. Thecriteria that is used to determine the particular size and configurationis the blood vessel condition at the puncture BVP and thecross-sectional size and shape of the blood vessel lumen BVL in thevicinity of the puncture BVP. The largest cross-sectional dimension ofthe expanded tamponading member 21 must be small enough for the member21 to be pulled back against the interior end of the puncture BVPwithout dragging or hanging up in the blood vessel lumen BVL. It hasbeen found that an expanded dimension in one direction for the member 21that is at least about 1.5 times larger than the puncture BVP issatisfactory to prevent the tamponading member 21 from being pulled backthrough the puncture BVP under typical conditions. That portion of thetamponading member 21 at the puncture BVP must be larger than the sizeof the puncture BVP to insure sealing when the tamponading member 21 ispulled back up against the interior end of the puncture BVP as willbecome more apparent. While different expanded sizes may be used,dimensions on the order of 0.1500.200 inch (3.8-5.1 mm) should besuccessful under typical conditions where the puncture BVP is made witha 4 french puncture.

Without limiting the scope of the invention, the particular tamponadingmember 21 illustrated in FIG. 3 is a small inflatable balloon which canbe inflated to a size and configuration sufficiently larger than theblood vessel wall puncture BVP to prevent the expanded balloon member 21from being pulled back through the puncture BVP while at the same timenot hanging up in the blood vessel lumen BVL in its expanded condition.In the expanded condition, the member 21 has a puncture facing side thatis substantially normal to the centerline of the control member 20. Theinflatable balloon member 21 may be made out of any suitable materialsuch as latex. The balloon member 21 is inflated and deflated throughthe control member 20 as will become more apparent.

The control member 20 is a thin elongate member similar in size andflexibility to the guide wire used to originally install the sheath GSin the access passage AP. The control member 20 is sufficiently long toextend from within the blood vessel lumen BVL out through the punctureBVP and the access passage AP exteriorly of the patient so that it canbe manually manipulated and is also long enough that the guide sheath GScan be removed while manually holding the expanded tamponading member 21in place over the puncture BVP to maintain the seal. To permit theballoon member 21 to be inflated, the control member 20 defines aninflation lumen 28 therein seen in FIGS. 3 and 4 that extends from andcommunicates with the interior of the balloon member 21 along the lengthof the member 20 and opens out through the coupling 25. Thus, theballoon tamponading member 21 can be inflated and deflated through thelumen 28 from a position external to the patient.

The balloon member 21 is inflated by any convenient fluid inflationdevice such as the syringe 26 illustrated. Typically, the syringe 26 orother inflation device will be of the same type as that already used inballoon angioplasty and has an extension 31 sized similarly to thecontrol member equipped with a mating coupling 30 to be selectivelyconnected to the coupling 25 on the end of the control member 20. Theinflation fluid under pressure from the syringe 26 flows along theinflation lumen 28 in the control member 20 into the balloon member 21to inflate same.

In those instances where it is necessary to remove the inflation device26 after the balloon member 21 is inflated to the expanded condition tocomplete the insertion of the collagen plug into the access passage AP,the balloon member 21 can be maintained inflated by providing a checkvalve 29 on the exterior end 24 of the control member 20. The checkvalve 29 may be incorporated in the coupling 25 or be a separate memberas shown in the drawings at FIG. 4. To deflate the balloon member 21after the procedure is complete, the physician can insert a needle intothe valve 29 to open it or if the valve is a separate member, the valve29 can simply be removed from the coupling 25. The outside diameter ofthe member 20 including the coupling 25 and the check valve 29 should beas small as possible in order to pass freely through the puncture BVPand to pass through the collagen plug 12 without significantlydisturbing it. While different diameters may be used, diameters of0.030-0.050 inch (0.8-1.3 mm) are satisfactory.

The applicator 14 best seen in FIGS. 1 and 2 includes a housing assembly35 which mounts an introducer assembly 36 to house the collagen plug 12while it is inserted into the access passage AP. A retraction mechanism38 withdraws the introducer assembly 36 from around the collagen plug 12after it is inserted in the patient. An interconnect assembly 39interconnects the control member 20 and the applicator 14 to positivelylocate the tamponading member 21 with respect to the introducer assembly36 is being withdrawn from around the collagen plug. A locator mechanism40 is provided on the housing assembly 35 to be adjusted for a secondaryfixed point of reference as the introducer assembly 35 is beingwithdrawn from around the collagen plug by the retraction assembly 38.

The housing assembly 35 includes an elongate cylindrical body 45 with ahand grip 46 on one end thereof. The body defines an introducer passage48 seen in FIG. 2 centrally therethrough that receives the introducerassembly 36 therein. A side slot 49 is defined through the wall of thebody 45 and extends lengthwise of the body in alignment with the handgrip 46 for the manually engageable portion of the retraction mechanismto extend for manipulation.

The introducer assembly 36 includes a thin wall insertion barrel 50slidably mounted in the body 45 of the housing assembly 35. The barrelhas a projecting end 51 thereon that is inserted into the access passageAP and an opposite rear end. The barrel 50 defines a collagen plugreceiving passage therein and is provided with an inwardly directedflange 52 at the rear end thereof. The barrel 50 has a length sufficientfor the barrel to project from the body 45 far enough for the barrel toextend along the access passage AP to the wall of the blood vessel BV.The barrel 50 is slidably mounted over a locator plunger 55 carried bythe body 45 of the housing assembly 35 to maintain the collagen plug inplace as the installation barrel 50 is being retracted. The plunger 55has an enlarged head 56 on the projecting end thereof which fills thecross-sectional space in the plug receiving passage under the flange 52when the barrel is fully extended. The smaller diameter support shaft 58of the plunger 55 slidably extends through the opening in the flange 52and is attached to the rear end of the body 45. Thus, as the barrel 50is pulled back along the plunger 55, the head 56 of the plunger holdsthe collagen plug in a fixed position with respect to the housingassembly 35 as will become more apparent. The projecting face of thehead 56 is spaced from the projecting end of the barrel 50 a distancesubstantially equal to the length of the collagen plug 12 when thebarrel 50 is fully extended from the body 45 with the flange 52 on thebarrel 50 against the rear annular face of the head 56 to insure thatthe plug will be properly in position.

The retraction mechanism 38 is attached to the barrel 50 and projectsthrough the slot 49 through the body 45. The mechanism 38 may be anyconvenient arrangement which can retract the barrel 50 into the body 45.The mechanism 38 illustrated as an example includes a connector ring 60attached to the rear side of the flange 52 on the barrel 50 to slide inthe passage 48 with the barrel and a manually engagable actuator member61 attached to the ring 60 and projecting out through the slot 49 to bemanually engaged and pulled back toward the hand grip 46 pulling thebarrel 50 therewith. The actuator member 61 is resiliently connected tothe ring 60 so that it is urged away from the ring and is equipped witha ratchet pawl 62 that prevents the ring 60 and thus the barrel 50 frommoving toward the trailing end of the body 45 until the actuator member61 is pulled back toward the hand grip 46. This action pivots theactuator member 61 and the ratchet pawl 62 out of engagement with thewall of the body 45 to release the barrel 50 for retraction.

The applicator 14 has a prescribed overall length L₁ when the barrel 50is extended. This length cooperates with the control member 20 to letthe physician know when the projecting end 51 of the barrel 50 islocated at the blood vessel wall BVW. The control member 20 is markedwith appropriate indicia 65 that will be exposed at the trailing end ofthe applicator 14 when the projecting end of the barrel and thus thecollagen plug is located at the exterior end of the puncture BVP throughthe wall of the blood vessel. Any appropriate indicia may be used,however, for purposes of illustration, the indicia 65 is shown is asafety band 66 spaced so that, as long as the safety band 66 is visibleon the trailing end of the applicator 14, the leading end of thecollagen plug 12 is located in the vicinity of the exterior end of thepuncture BVP. To prevent overinsertion of the collagen plug 12 into thepuncture, a warning band 68 is positioned inboard of the band 66 sothat, if the band 68 is visible, the plug 12 is overinserted into thepuncture BVP.

The interconnect assembly 39 is mounted on the housing assembly 35 andserves to grip the control member 20 on the sealing assembly 11 tointerrelate the position of the applicator with the control member. Theinterconnect assembly 39 has a one way gripping arrangement 70 withappropriate ratchet teeth that permit the arrangement 70 and tamponadingmember 21 to move toward each as the arrangement 70 slides along thecontrol member 20 but prevents motion in the opposite direction. Thus,once the applicator 14 is on the control member 20, it can only beslipped toward the tamponading member 21. This serves to hold thehousing assembly 35 substantially fixed with respect the control memberand thus the tamponading member 21 while the barrel 50 is beingretracted.

The interconnect assembly 39 also has a tightening arrangement 71 whichslightly tightens the tamponading member 21 against the inside end ofthe puncture BVP while the barrel 50 is being withdrawn from around thecollagen plug 12. The tightening arrangement 71 is connected to theretraction mechanism 38 and the gripping arrangement 70 so that thegripping arrangement 70 is moved with the barrel 50 when the barrelinitially moves. The arrangement 71, however, releases the retractionmechanism 38 after the gripping arrangement 70 has moved the controlmember 20 a prescribed short distance which insures that the punctureBVP remains closed but insufficient to pull any portion of thetamponading member 21 through the puncture BVP.

The tightening arrangement 70 includes an extension 75 on the connector60 that projects rearwardly along the passage 48 to the rear end of thebody 45. The rearwardly projecting end of the extension 75 has a detentengaging cavity 76 therein. The forwardly projecting portion of thegripping arrangement 70 is connected to a resilient extension 78 with adetent 79 thereon that fits into the cavity 76 of the extension 75. Thenatural resiliency of the extension 78 urges the detent 79 inwardly outof the cavity 76 to disconnect the extension 78 from the extension 75.The passage 80 through the end of the body 45 keeps the detent 79 andcavity 76 forced together until the forwardly projecting end of theextension 78 moves into registration with a release cavity 81 in thebody 45 opening into the passage 80. This releases the grippingarrangement 70 from the extension 75 on the tightening arrangement 70and also holds the gripping arrangement 70 in a fixed position withrespect to the body 45 while the extension 75 continues to move with theretraction of the barrel 50.

The locator mechanism 40 includes a locator pad 85 defining a centralpassage therethrough to the slidably fit over the barrel 50. A tubularmember 86 is attached to the pad 85 and extends over the forward end ofthe body 45. The member 86 is divided into rearwardly directed resilientstrips 88 that are equipped with inwardly facing one way grippers thatcooperate with complementary grippers 89 on the outside of the body 45.The grippers are arranged to permit the locator mechanism 40 to be movedout over the barrel 50 until the pad 85 is against the skin but preventsmovement in the opposite direction. This provides a secondary method forlocating the applicator 14 with respect to the blood vessel wallpuncture BVP.

To compensate for any loss of volume in the collagen plug 12 as itbecomes a gelatinous mass, a compensator assembly 90 is provided. Whiledifferent mechanisms may be used, the assembly 90 shown for purposes ofillustration is mounted in the projecting end of the enlarged head 56 onthe plunger 55 and is activated as an incident to the retraction of thebarrel 50 off of the collagen plug 12. The assembly 90 includes a pusherplate 91 with a support tube 92 slidably extending into an annularpassage in the head 56 and opening onto the end thereof. The plate 91 isurged out of the head 56 by a spring 94 captured between the end of thetube 92 and the bottom of the passage. The tube 92 has a limiting stopon it to limit the extension of the plate 91 away from the end of thehead 56. The amount of possible extension from the head 56 is selectedto correspond to the plug volume lost as the plug softens. The strengthof the spring 94 is limited so that the plate 91 will not force the plug12 through the puncture BVP. The plate 91 is held in the retractedposition until the barrel 50 releases the plug by the friction betweenthe plug and the barrel 50.

Method of Use

The method of sealing a blood vessel using the first embodiment of theinvention is illustrated in FIGS. 5-9. As seen in FIG. 5, the temporarysealing assembly 11 is installed while the introducer guide sheath GS isstill in position. The temporary sealing assembly 11 is installed bythreading the projecting end 22 thereof down through the guide sheath GSand into the blood vessel lumen BVL The control member 20 is threadedthrough the guide sheet GS until the collapsed tamponading member 21passes into the blood vessel lumen BVL as seen in FIG. 5. Thereafter,the tamponading member 21 is expanded to its expanded condition with thesyringe 26 and the guide sheath GS is removed. The physician physicallypulls back on the control member 20 so that the expanded tamponadingmember 21 is pulled back up against the inside end of the puncture BVPthrough the blood vessel wall. The tamponading member 21 is illustratedin the sealing position in FIG. 6.

After the tamponading member 21 is pulled up against the inside end ofthe puncture BVP, the applicator 14 with the collagen plug 12 therein isinserted over the exterior end 24 of the control member 20 so that theapplicator and collagen plug is slipped toward the patient's skin. Itwill be appreciated that the physician holds the control member 20 tomaintain the pressure of the tamponading member 21 against the insideend of puncture BVP at all times. After the applicator and collagen plugare inserted over the control member 20 as seen in FIG. 6, the physiciancarefully slides the applicator 14 along the control member 20 so thatthe insertion barrel 50 on the introducer assembly 36 passes into theaccess passage AP through the skin and tissue. The physician continuesto push the applicator 14 toward the patient while holding the controlmember 20 to keep the tamponading member 21 in place until the safetyband 66 of the indicia 65 on the control member 20 becomes visible atthe trailing end of the applicator 14. At this time, the projecting end51 of the barrel 50 is located in the vicinity of the outside end of thepuncture BVP through the blood vessel wall BVW as seen in FIG. 7.

Since the one way gripping arrangement 70 of the interconnect assembly39 prevents the applicator 14 from being moved back up the controlmember 20, the collagen plug carried in the end of the barrel 50 ispositively located with respect to the blood vessel wall puncture BVP.The physician then slides the locator mechanism 40 out along the body 45until the locator pad 85 lies at the skin surface SS. This serves tostabilize the applicator 14 and also to act as a secondary reference tolocate the applicator 14 with respect to the outside end of the bloodvessel wall puncture BVP as is also shown in FIG. 7. The barrel 50 isnow ready to be withdrawn from around the collagen plug 12 since thehousing assembly 35 is fixed relative to the control member 20. Thehousing 35 remains stationary while the physician pulls the actuatormember 61 back toward the hand grip 46. This serves to retract thebarrel 50 while leaving the housing assembly 35 in place so that thelocator plunger 55 holds the collagen plug 12 in place. Although thebarrel 50 does not have to be fully retracted before the procedure iscompleted, it typically is fully retracted as seen in FIG. 8 to leavethe plug 12 in position in the access passage AP. As soon as the bodyfluids contact the plug 12, it starts to soften and any seepage of bloodthrough the blood vessel puncture BVP serves to start the formation of acoagulum at the exterior end of the puncture BVP. Typically, theapplicator 14 is left in position while the tamponading member 21 iscollapsed back to its original position and the control member 20 pulledto pull the tamponading member 21 back through the collagen plug 12 intothe applicator 14. By having a projecting end 22 on the control member20 long enough to still reach into the blood vessel lumen BVL with thetamponading member 21 within the applicator 14, contact is not lost withthe blood vessel lumen if something causes the collagen plug 12 not toproperly seal. This will facilitate re-access to the blood vessel lumenBVL. After the physician checks to see if the seal has been affected,the projecting end of the control member 20 can be pulled out throughthe collagen plug 12 to complete the procedure and leave the collagenplug 12 in place forming the coagulum CAM as seen in FIG. 9.

Alternate Embodiment of Sealing Assembly

FIG. 10 shows an alternate embodiment of the sealing assembly which hasbeen designated as 111. The sealing assembly 111, like the sealingassembly 11, has an elongate flexible control member 120 with anexpandable tamponading member 121 mounted on the control member 120. Inaddition to the inflation lumen 128 which is provided through thecontrol member 120, an injection lumen 132 is provided along the lengthof the control member 120 and exits the control member 120 adjacent thetrailing end of the tamponading member 121 that faces the blood vesselwall puncture BVP. The size of the discharge port 134 through which theinjection lumen exits is selected to have a longitudinal length L₁ asseen in FIG. 10. The length L₁ is selected to be less than the thicknessof the blood vessel wall BVW at the puncture BVP. An appropriateinjection port (not shown) to the injection lumen 132 is provided in theexterior end of the control member 120.

This allows the physician to inject a detectable fluid through theinjection lumen 132 and out the port 134 as the expanded tamponadingmember 121 is pulled back toward the puncture BVP. The physician canmonitor the flow of the protectable fluid along the blood vessel lumenBVL with appropriate equipment such as fluoroscopy. The physiciancontinues to pull the tamponading member 121 toward the wall BVW untilthe flow of the detectable fluid along the lumen BVL is stopped. Thisensures that the tamponading member 121 does not hang up on occlusionsor plaque within the blood vessel lumen and not seat good against theblood against the blood vessel wall BVW.

Second Embodiment of Applicator

The second embodiment of the applicator is designated 114 and isillustrated in FIGS. 11-15. The basic difference between the applicator114 and the applicator 14 is that the applicator 114 has an open sectionthrough which the control member on the temporary sealing assembly canbe installed without feeding the control member axially through thecollagen plug and applicator. The applicator 114 like the applicator 14,includes a housing assembly 135, and introducer assembly 136, aretraction mechanism 138, an interconnect assembly 139, and a locatormechanism 140. These assemblies and mechanisms operate similarly to thecorresponding assemblies and mechanisms of the first embodiment of theinvention.

The cylindrical body 145 defines a V-shaped cutout 147 therein down tothe passage through which the control member on the temporary sealingassembly passes so that control member can be laid into the passage asit is being operated to install the collagen plug. The insertion barrel150 of the introducer assembly 136 is slit at 141 along its length andthe sidewall thereof is turned slightly inwardly so that the controlmember on the temporary sealing assembly can be pressed therethrough.This slit 141 is also defined through the inwardly directed flange 152.The locator plunger 155 is provided with a V-shaped cutout 142 thatextends from the central passage through which the control member passesto the exterior surface thereof. Similarly, the gripping arrangement 170on the interconnect assembly 139 is provided with a V-shaped cutout 143to allow the control member to be placed laterally into the passage upthrough the arrangement 170. It will be appreciated that the arrangement170 still is able to grip the control member during use as with thefirst embodiment of the invention. Likewise, the locator pad 185 andtubular member 186 have a V-shaped cutout 144 to allow the controlmember to pass through the center thereof. The body 145 is provided witha closure 195 that closes the rear portion of the cutout through thebody 145 to keep the control member in place once it is placed in thecentral passage running through the applicator.

The collagen plug 112 used with the second embodiment of the applicatoris illustrated in FIGS. 12 and 15 and includes a thin V-shaped cutout196 which extends to the central passage through the plug 112 to receivethe control member of the temporary sealing arrangement. While the plug112 may work with a single V-shaped cutout 196, it is illustrated with awider opening section 198 adjacent the exterior surface thereof tofacilitate placement of the control member therein. It will be notedthat the cutout comes together just before the central passage throughthe plug 112 is reached so that, once the control member is snapped intothe passage through the plug, it is retained therein.

Third Embodiment of the Invention

FIGS. 16 and 17 illustrate a third embodiment 210 of the invention whichincludes a collagen plug 212 and an applicator tube 214. The collagenplug 212 is installed on the control member and the extension 31 to thesyringe 26 as described with the first embodiment of the invention. Theapplicator tube 214 is a cylindrical tube defining a central passagetherethrough to just slidably receive the control member of thetemporary sealing arrangement. The physician simply slides the collagenplug 212 and the tube 214 onto the control member of the temporarysealing arrangement so that the leading end of the collagen plug 212faces the access passage AP in the patient. The physician then uses theapplicator tube 214 to push the collagen plug 212 down to the outsideend of the puncture BVP. The combined overall length of the collagenplug 212 and the applicator tube 214 corresponds to that of the firstembodiment of the invention so that the physician can use the indicia 65on the temporary sealing assembly to determine when the leading end ofthe collagen plug 212 is located in the vicinity of the outside end ofthe puncture BVP.

The collagen plug 212 is made so that an outside layer 215 thereon has aprescribed spring and softening rate so that the plug 212 will notsoften prior to being fully inserted into the access passage AP. Thetapered leading end 216 on the collagen end 212 serves to keep thecollagen plug centered in the access passage AP and open it up toreceive the plug 212. The higher strength at the trailing end of thecollagen plug 212 permits the applicator tube 214 to push it into placebefore the plug softens.

Fourth Embodiment of the Applicator

FIG. 18 illustrates an alternate embodiment of the applicator which hasbeen designated by the reference of 314. The applicator 314 include aninsertion barrel 150 with the projecting end 351 thereon adapted to beinserted into the access passage AP in the patient. The barrel 350defines an internal passage therethrough adapted to slidably receive thecollagen plug 12 therein. A one-way check member 353 is mounted in thebarrel 350 behind the plug 12 and has a face thereon abutting the plug12 to maintain it lengthwise of the barrel 350 as will become moreapparent. The check member 353 defines a tamponading member receivingchamber 352 which opens onto the trailing end of the plug 12 andtrailing end of the check member 353 is provided with a one-way grippingassembly 354 which grips the control member of the temporary sealingarrangement to allow the check member 353 to be moved along the controlmember toward the expanded tamponading member but prevents movement ofthe check member 353 in the opposite direction. A locator plunger 355extends into the barrel 350 behind the check member 353 to maintain thecheck member 353 in position relative to the collagen plug 12 as thecollagen plug 12 is being installed. An appropriate drive flange 356 isprovided on the trailing end of the plunger 355 projecting out of thebarrel 350 to be manually engaged. The leading end of the plunger 355 iscounterbored at 358 to receive the projecting portion of the checkmember 353 therein so that the leading end of the locating plunger abutsthe back side of the check member 353. The holding ring 359 is providedon the trailing end of the barrel 350 so that the physician can holdboth the flange 356 and the ring 359 to simultaneously push both theplunger 355 and the barrel 350 into the access passage AP. As soon asthe leading end of the collagen plug 112 is located in the vicinity ofthe outside end of the puncture BVP, the barrel 350 can be withdrawnfrom around the collagen plug 12 simply by pulling out on the plunger356 and the member 353. This is because the check member 353 preventsthe collagen plug 12 from being withdrawn with the barrel 350. After thecollagen plug 12 is installed and the temporary sealing assembly isready to be withdrawn, the physician can hold the back side of the plug12 while the collapsed tamponading member 21 is pulled through the plug12 into the recess 352. Because the projecting end 22 on the controlmember 20 is smaller than the collapsed tamponading member 21, the restof the control member can be pulled out of the plug 12 without damagingthe plug.

1-10. (canceled)
 11. A system for depositing a sealing material forsealing a puncture in a body cavity wall of a body cavity of a patientcomprising: a temporary sealing assembly comprising: an elongate controlmember having a length greater than the length of the puncture to besealed and a cross-sectional area smaller than that of the puncture tobe sealed so that the control member passes through the puncture; and anexpandable member mounted on said elongate control member at a firstprescribed axial position so that a portion of the control memberextends exteriorly of the patient when said expandable member is locatedwithin the body cavity, the expandable member having a collapsedcross-sectional size smaller than that of the puncture and an expandedcross-sectional size larger than that of the puncture to prevent passageof the expanded expandable member through the puncture so that theelongate control member can be used to pull the expanded expandablemember in the body cavity up against that end of the puncture openinginto the body cavity; and an applicator comprising: an introducer memberdefining a sealing material chamber therein and a projecting endthereon, the sealing material chamber opening onto the projecting end ofthe introducer member, a plunger slidably mounted within the introducermember, the plunger movable between an initial position in which asealing material is housed within said sealing material chamber and awithdrawn position in which the introducer member is withdrawn fromaround the sealing material while the sealing material is held inposition by the plunger, the plunger defining a central passagetherethrough sized to allow the control member to slide therethrough,and an interconnect structure connected to the elongate control memberand positioned so as to fix the plunger at an axial position withrespect to the elongate control member so that the position of thesealing material with respect to the puncture is maintained as theintroducer member is withdrawn from around the sealing material.
 12. Thesystem of claim 11, wherein the interconnect structure is a ridgelocated around the control member of thickness sufficient to fix theposition of the plunger but to allow the introducer member to bewithdrawn over the interconnect structure.
 13. The system of claim 11,wherein the interconnect structure permits withdrawal of the controlmember through the sealing material and through the puncture after theexpandable member is collapsed.
 14. The system of claim 11, wherein thesealing material is a preformed member having a preformed cylindricalpassage through which the elongate control member passes.
 15. The systemof claim 11, wherein the sealing material is a flexible material that iswrapped around the elongate control member before the sealing materialis inserted into the puncture.
 16. The system of claim 11, wherein thepuncture is in the wall of a blood vessel.
 17. The device of claim 11,wherein the system further comprises an indicia for deploying thesealing material in the puncture and outside the body cavity.
 18. Thedevice of claim 11, wherein the system further comprises a lockingmechanism used for deploying the sealing material in the puncture andoutside the body cavity.
 19. A device for sealing a puncture in a bodycavity wall of a body cavity of a patient comprising: a control memberhaving a length greater than the length of the puncture to be sealed anda cross-sectional area smaller than that of the puncture to be sealed sothat the control member can be inserted into the puncture; and anexpandable member fixed to the control member at a first axial positionso that a portion of the control member extends exteriorly of thepatient when said expandable member is located within the body cavity,the expandable member having a collapsed configuration that fits throughthe puncture and an expanded configuration that prevents passage of theexpanded expandable member through the puncture so that the elongatecontrol member can be used to pull the expanded expandable member in thebody cavity up against that end of the puncture opening into the bodycavity; and an introducer member mounted on the control member, theintroducer member having a proximal end and a distal end, the distal endcomprising a sealing material mounted on the control member.
 20. Thedevice of claim 19, wherein the sealing material is wrapped around thecontrol member.
 21. The device of claim 19, wherein the sealing materialis fixed to the control member so as to remain axially fixed in placewhile the introducer member is withdrawn from the puncture.
 22. Thedevice of claim 19, wherein the sealing material is withdrawn from thepuncture with the control member after hemostasis begins.
 23. The deviceof claim 19, wherein the introducer member is operable to deploy thesealing material in the puncture adjacent to the body cavity wall. 24.The device of claim 19, wherein the puncture is in the wall of a bloodvessel.
 25. The device of claim 19, wherein the device further comprisesan indicia for deploying the sealing material in the puncture andoutside the body cavity.
 26. The device of claim 19, wherein the devicefurther comprises a locking mechanism used for deploying the sealingmaterial in the puncture and outside the body cavity.
 27. A method ofsealing a puncture in a cavity wall of a body cavity of a patientcomprising the steps of: inserting an expandable member attached to acontrol member into the body cavity through the puncture while theexpandable member is in a collapsed condition with a cross-sectionalarea smaller than the cross-sectional area of the passage so that thecontrol member extends out of the body cavity and the punctureexteriorly of the patient; expanding the expandable member to anexpanded condition having a cross-sectional area greater than thecross-sectional area of the puncture; pulling the expandable member backagainst the puncture in the cavity wall using the control member so asto close the puncture in the cavity wall; inserting an introducer memberinto the puncture until the distal end of the introducer member reachesthe distal end of the puncture, the introducer member comprising aplunger and a sealing material; and withdrawing the introducer memberfrom the puncture while the plunger and the sealing material remain atthe distal end of the puncture.
 28. The method of claim 27, furthercomprising the steps of: collapsing the expandable member to a collapsedcondition having a cross-sectional area smaller than the cross-sectionalarea of the puncture; withdrawing the control member and the collapsedexpandable member from the body cavity.
 29. The method of claim 27,further comprising the steps of: collapsing the expandable member to acollapsed condition having a cross-sectional area smaller than thecross-sectional area of the puncture; withdrawing the control member andthe collapsed expandable member through the sealing material in thepuncture.
 30. The method of claim 27, wherein the sealing material is apreformed cylindrical member with a cylindrical passage along the lengthof the preformed cylindrical member.
 31. The method of claim 27, whereinthe sealing material is a preformed cylindrical member with an openingalong its length so that the preformed cylindrical member can be placedon the control member passing through the plunger and the introducermember.
 32. The device of claim 27, wherein the puncture is in the wallof a blood vessel.
 33. The device of claim 27, wherein the step ofinserting the introducer member into the puncture until the distal endof the introducer member reaches the distal end of the puncture furthercomprises reading an indicia indicating the sealing material ispositioned in the puncture and outside the body cavity.
 34. The deviceof claim 27, wherein the step of inserting the introducer member intothe puncture until the distal end of the introducer member reaches thedistal end of the puncture further comprises engaging a lockingmechanism so that the sealing material is positioned in the puncture andoutside the body cavity.
 35. A method for sealing a puncture in a cavitywall of a body cavity of a patient comprising the steps of: inserting adevice into the puncture, the device comprising an expandable memberattached to a control member with a distal end of the control member andthe expandable member extending into the body cavity through thepuncture while the expandable member is in a collapsed condition so thata proximal end of the control member extends out of the body cavity andthe puncture exteriorly of the patient; and an introducer memberextending into the puncture until a distal end of the introducer memberreaches a distal end of the puncture, the distal end of the introducermember comprising a sealing material; expanding the expandable member toan expanded condition that prevents passage of the expandable memberthrough the puncture; and pulling the expandable member back against thepuncture in the cavity wall using the control member so as to positionthe control member and the distal end of the introducer member.
 36. Themethod of claim 35, further comprising the step of withdrawing theintroducer member from the puncture while the sealing material remainsat the distal end of the puncture.
 37. The method of claim 35, furthercomprising the step of withdrawing the introducer member from thepuncture while the sealing material remains fixed to the control memberat the distal end of the puncture.
 38. The method of claim 35, furthercomprising the steps of collapsing the expandable member and withdrawingthe control member with the sealing material after hemostasis begins.39. The method of claim 35, wherein the sealing material comprises anopening along its length allowing the sealing material to be wrappedaround the control member.
 40. The method of claim 35, furthercomprising the steps of: deploying the sealing material at the distalend of the puncture; collapsing the expandable member to a collapsedcondition; and withdrawing the control member and the collapsedexpandable member through the sealing material in the puncture.
 41. Themethod of claim 35, wherein the puncture is in the wall of a bloodvessel.
 42. The method of claim 35, further comprising the step ofreading an indicia indicating the sealing material is positioned in thepuncture and outside the body cavity.
 43. The method of claim 35,further comprising the step of engaging a locking mechanism so that thesealing material is positioned in the puncture and outside the bodycavity.